Anti-oxidant Therapy and Postoperative Cardiac Events (ACE) Trial, Preoperative Intervention in Vascular Surgery
ACE
1 other identifier
interventional
341
1 country
1
Brief Summary
N Terminal (NT)-Pro b-type natriuretic peptide (BNP) levels provide incremental value in perioperative risk assessment prior to major non-cardiac surgery. The investigators will test whether pharmacologically lowering this biomarker with daily administration of CoQ10 for 3 days prior to elective vascular surgery will reduce adverse outcomes following the operation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2013
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 5, 2013
CompletedFirst Submitted
Initial submission to the registry
May 16, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2022
CompletedAugust 31, 2021
August 1, 2021
9 years
May 16, 2019
August 30, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
BNP levels following surgery
Peak values
48 hours
Cardiac Troponin levels following surgery
Peak values
48 hours
Change in Troponin levels from baseline to peak
Change from baseline to peak
48 hours
Number of participants with adverse cardiac outcomes following surgery
Myocardial Infarction (MI) and death
48 hours
Secondary Outcomes (8)
Number of participants who died
30 days
Number of participants requiring coronary revascularization
30 days
Number of participants with new heart failure
30 days
Number of participants with new onset Atrial Fibrillation (A-Fib)
30 days
Number of participants with infection
30 days
- +3 more secondary outcomes
Study Arms (2)
Ubiquinone
EXPERIMENTALTake oral tablets as directed (2x200 mg for 3 days prior to surgery)
Placebo
PLACEBO COMPARATORTake oral tablets as directed (2x200 mg for 3 days prior to surgery)
Interventions
Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
Eligibility Criteria
You may qualify if:
- ELECTIVE HIGH RISK NON-CARDIAC SURGERY
You may not qualify if:
- REACTION TO COQ10
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Va Medical Center
Minneapolis, Minnesota, 55417, United States
Related Publications (1)
Khan A, Johnson DK, Carlson S, Hocum-Stone L, Kelly RF, Gravely AA, Mbai M, Green DL, Santilli S, Garcia S, Adabag S, McFalls EO. NT-Pro BNP Predicts Myocardial Injury Post-vascular Surgery and is Reduced with CoQ10: A Randomized Double-Blind Trial. Ann Vasc Surg. 2020 Apr;64:292-302. doi: 10.1016/j.avsg.2019.09.017. Epub 2019 Oct 17.
PMID: 31629852DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
EDWARD MCFALLS, MD
SITE PI
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- CARDIOLOGIST
Study Record Dates
First Submitted
May 16, 2019
First Posted
May 20, 2019
Study Start
August 5, 2013
Primary Completion
August 4, 2022
Study Completion
August 4, 2022
Last Updated
August 31, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share
Sharing plan will be left at the discretion of the VA funding organization and statistical site.